Ganaxolone for use in treating tuberous sclerosis complex
The disclosure to methods for treating tuberous sclerosis complex or tuberous sclerosis complex-related epilepsy, comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutically acceptable pregnenolone neurosteroid, such as ganaxolone, to reduce one or more symptoms of tuberous sclerosis complex or tuberous sclerosis complex-related epilepsy.
1. A method for treating tuberous sclerosis-related epilepsy comprising administering to a subject in need thereof a therapeutically effective amount of ganaxolone, wherein the therapeutic effectively amount is administered orally three times per day.
2. The method of claim 1 , wherein ganaxolone is administered as an oral suspension.
3. The method of claim 1 , wherein ganaxolone is administered as an oral capsule.
4. The method of claim 1 , wherein ganaxolone is administered as a tablet.
5. The method of claim 1 , wherein the therapeutically effective amount is an amount sufficient to produce a ganaxolone plasma concentration of at least about 100 ng/ml for at least about 70% or more per day.
6. The method of claim 1 , wherein the therapeutically effective amount is no more than about 1800 mg per day.
7. The method of claim 6 , wherein the therapeutically effective amount is about 600 mg three times per day.
8. The method of claim 1 , wherein the therapeutically effective amount is no more than about 1500 mg per day.
9. The method of claim 8 , wherein the therapeutically effective amount is about 500 mg three times per day.
10. The method of claim 1 , wherein the therapeutically effective amount is no more than about 63 mg/kg per day.
11. The method of claim 10 , wherein the therapeutically effective amount is about 21 mg/kg three times per day.
12. A method for treating tuberous sclerosis-related epilepsy comprising administering to a subject in need thereof a therapeutically effective amount of ganaxolone that is sufficient to produce a ganaxolone plasma concentration of at least about 100 ng/ml over a period of at least about 70% of a day.
13. The method of claim 12 , wherein the subject is administered ganaxolone three times per day.
14. The method of claim 12 , wherein ganaxolone is administered orally.
15. The method of claim 14 , wherein ganaxolone is administered as an oral suspension.
16. The method of claim 14 , wherein ganaxolone is administered as an oral capsule.
17. The method of claim 16 , wherein ganaxolone is administered as a tablet.
18. The method of claim 12 , wherein ganaxolone is administered as an intravenous infusion.
19. The method of claim 12 , wherein the therapeutically effective amount is no more than about 1800 mg per day.
20. The method of claim 19 , wherein the therapeutically effective amount is about 600 mg three times per day.
21. The method of claim 12 , wherein the therapeutically effective amount is no more than about 1500 mg per day.
22. The method of claim 21 , wherein the therapeutically effective amount is about 500 mg three times per day.
23. The method of claim 12 , wherein the therapeutically effective amount is about 63 mg/kg per day.
24. The method of claim 23 , wherein the therapeutically effective amount is about 21 mg/kg three times per day.
25. The method of claim 12 , wherein the tuberous sclerosis complex-related epilepsy is an infantile spasm, a focal impaired awareness seizure, a focal seizure, or a generalized seizure.